(79 days)
K922575/A
Not Found
No
The device description and performance studies focus on the physical properties and safety of a menstrual pad, with no mention of AI or ML technology.
No
The device is described as an unscented menstrual pad for absorption of menstrual and other vaginal discharge, and for absorption of urine loss associated with light incontinence. Its function is to absorb fluid, not to treat or cure a disease or condition.
No.
The device is described as an absorbent pad for menstrual and vaginal discharge and light urine loss, with no mention of diagnosing conditions or providing diagnostic information.
No
The device description clearly outlines physical components (topsheet, absorbent core, backsheet, adhesive) and the intended use is for absorption, indicating a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a menstrual pad for absorbing bodily fluids (menstrual discharge, vaginal discharge, and urine). It does not perform any analysis or testing of these fluids to provide diagnostic information.
- Intended Use: The intended use is for absorption, not for diagnosing any condition.
- Performance Studies: The performance studies mentioned are safety tests (microbiological, biocompatibility, extraction), not studies evaluating the diagnostic accuracy of the device.
The device is a Class II medical device intended for external use to manage bodily fluids.
N/A
Intended Use / Indications for Use
Always® are unscented menstrual pads for absorption of menstrual and other vaginal discharge, and for absorption of urine loss associated with light incontinence due to stress-related activities such as laughs, coughs, sneezes and exercise.
Product codes (comma separated list FDA assigned to the subject device)
HHD
Device Description
The menstrual pad device has 4 primary components, 1) The permeable topsheet allows fluid to pass through into the core; 2) the absorbent core acquires and stores fluid; 3) the impermeable backsheet prevents fluid transfer beyond the core; 4) the attachment adhesive holds the pad in place, The absorbent core is held in place between the topsheet and the backsheet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A battery of safety tests was conducted, including in vitro microbiological testing, biocompatibility testing and extraction testing, to evaluate the safety profile of the 510(k) device. The results of these safety tests support the conclusion that the 510(k) device is equally as safe an the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K922575/A
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.5435 Unscented menstrual pad.
(a)
Identification. An unscented menstrual pad is a device that is a pad made of cellulosic or synthetic material which is used to absorb menstrual or other vaginal discharge. This generic type of device includes sterile unscented menstrual pads used for medically indicated conditions, but does not include menstrual pads treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9 only when the device is made of common cellulosic and synthetic material with an established safety profile.
0
Section 5: 510(k) Summary
| Submitted by: | The Procter & Gamble Company
6110 Center Hill Avenue
Cincinnati, OH 45224 | 9-20-07 |
|------------------------|-----------------------------------------------------------------------------------------------------------------|---------|
| Contact Person: | Lenore Faulhaber, Ph.D., M.B.A.
Regulatory Affairs Manager
(513) 634-2466 (voice)
(513) 634-7364 (FAX) | |
| Date Summary Prepared: | July 2, 2007 | |
| Trade Name: | Always® unscented menstrual pad | |
| Common Name: | Unscented Menstrual Pad | |
| Classification Name: | Unscented Menstrual Pad (21 CFR 884.5435) | |
| Predicate Devices: | Always® ultra thin unscented menstrual pad
Always® Curves unscented menstrual pads
(K922575/A) | |
Device Description: The menstrual pad device has 4 primary components, 1) The permeable topsheet allows fluid to pass through into the core; 2) the absorbent core acquires and stores fluid; 3) the impermeable backsheet prevents fluid transfer beyond the core; 4) the attachment adhesive holds the pad in place, The absorbent core is held in place between the topsheet and the backsheet.
Intended Uses: Always® are unscented menstrual pads for absorption of menstrual fluid and other vaginal discharge, and for absorption of urine loss associated with light incontinence.
Technological Characteristics: The device is designed to acquire and hold menstrual fluids or light urine loss similar to the fluid handing capabilities of the predicate devices.
Safety Assessment: A battery of safety tests was conducted, including in vitro microbiological testing, biocompatibility testing and extraction testing, to evaluate the safety profile of the 510(k) device. The results of these safety tests support the conclusion that the 510(k) device is equally as safe an the predicate devices.
Conclusions: The results of evaluations for this device support the conclusions that it is safe for its intended use and substantially equivalent to the cited predicate devices with regard to safety and effectiveness.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 2 0 2007
Ms. Lenore Faulhaber, Ph.D.,M.B.A. Regulatory Affairs Manager The Procter & Gamble Company Product Safety & Regulatory Affairs 6110 Center Hill Avenue CINCINNATI OH 45224
Re: K071827
Trade Name: Always® Unscented Menstrual Pads Regulation Number: 21 CFR §886.5435 Regulation Name: unscented menstrual pad Regulatory Class: I Product Code: HHD Dated: July 2, 2007 Received: July 3, 2007
Dear Dr. Faulhaber:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 100 years from 1906-2006. The logo features the letters "FDA" in a bold, stylized font, with the word "Centennial" written below. The logo is surrounded by text that follows the curve of the circle.
Protesting and Promoting Public Health
2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section 4: Indications for Use Statement
510(k) Number (if known): K071827
Device Name: Always® unscented menstrual pad
Indications for Use:
Always® are unscented menstrual pads for absorption of menstrual and other vaginal discharge, and for absorption of urine loss associated with light incontinence due to stress-related activities such as laughs, coughs, sneezes and exercise.
Prescription Use (Part 21 CFR 801 Supbart D) AND/OR
Over-The-Counter Use X (21 CFR Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hester Renner
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K071827